Immune response and therapy assessment to COVID-19 Vaccinations in people with Diabetes Mellitus – an observational pilot study

Recruiting

• Conditions: E10; E11; Type 1 diabetes mellitus; Type 2 diabetes mellitus

• Registration Number: DRKS00024879
• Lead Sponsor: Division Exercise Physiology and Metabolism

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-06-02
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Planned COVID-19 vaccination(Each participant)

• Cohort I (Diabetes mellitus Type 1, well controlled)
Glycated haemoglobin levels HbA1c =7.5 %

• Cohort II (Diabetes mellitus Type 1, uncontrolled)
Glycated haemoglobin levels HbA1c >7.5 %

• Cohort III (Diabetes mellitus Type 2, well controlled)
Glycated haemoglobin levels HbA1c =7.5 %

• Cohort IV (Diabetes mellitus Type 2, uncontrolled)
Glycated haemoglobin levels HbA1c >7.5 %

Exclusion Criteria

•Active known malignancy within the last year excluding intraepithelial neoplasia of prostate, gastrointestinal tract and basalioma
•Pregnancy or intention of becoming pregnant; breastfeeding
•Immunosuppressive therapy
•Acute inflammatory disorder
•Alcohol abuse (more than 15 drinks / week)
•Any contraindication to the vaccine planned to receive as listed in the product characteristics
•Previous COVID-19 vaccine or episode of COVID-19

/ Healthy control group:
•Presence of disease or therapies that are likely to interfere with the immune response to vaccination
•Presence of a disease requiring change in therapy during 4 weeks prior to enrollment
•Any contraindications to the vaccine planned to receive as listed in the product characteristics
•Women who are pregnant, breastfeeding or not following adequate contraceptive measures
•Previous vaccination with any coronavirus vaccine or episode of COVID-19

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
• Difference in the change of anti-SARS-CoV-2 spike protein immune response measured by antigen-binding Ig assay from baseline to Visit 3 (2-3 weeks after the second vaccination) between people with diabetes (all 4 groups pooled) and healthy controls.